Tissue acquisition device with indication system

ABSTRACT

Among other things, there is disclosed a biopsy needle system in which the needle is capable of obtaining more than one length of sample. Generally, the needle includes an inner stylet, an outer cannula, and a handle connected to the stylet and cannula. The stylet has a notch that is extendable from the cannula to accommodate a tissue sample. An insert member is provided for attachment to the handle to make the amount of exposed notch smaller. Consequently, when the insert member is not attached to the handle, the needle can obtain a larger sample of tissue, and when the insert member is attached to the handle, the needle can obtain a smaller sample of tissue.

This application is a divisional of U.S. patent application Ser. No.14/211,595, filed Mar. 14, 2014 which claims the benefit of U.S.Provisional Application Ser. No. 61/789,924, filed on Mar. 15, 2013,which is incorporated herein by reference in its entirety.

The present disclosure concerns devices such as biopsy needles forobtaining a sample of human or animal tissue for testing or study. Inparticular, it concerns tissue-obtaining devices that allow a user toeasily assure that the device is correctly set for use even after userhas begun.

BACKGROUND

A variety of biopsy needles and similar devices for obtaining a tissuesample from a patient are known. Commonly, such devices include a thinneedle or stylet that can be inserted into the skin of the patient nearthe location of tissue to be sampled, such as suspected malignancies orother tissue of interest. Once the distal end or other cutting portionof the needle or stylet is within the tissue of interest, a portion ofthe tissue is excised and captured. The needle or stylet is withdrawnwith the tissue sample, which can be retrieved from the device andstudied.

Such products have proven quite effective in obtaining tissue in aminimally-invasive manner and with minimal discomfort to the patient.Their lightweight nature, combined with their ease of operation andreusability, make them excellent for sampling tissue that may present orindicate a health problem to the patient.

Biopsy needles designed to obtain samples of a fixed length arefamiliar, and in many cases that setting is either for a length ofsample of 10 mm or 20 mm. Biopsy needles or other tissue samplingdevices have been proposed that permit a variation of sample size, as byallowing the user to select or set the throw length to particulardiscrete settings for example. It can occur that the user forgets thesetting he or she has chosen, or whether he or she has properly cockedor set the device for taking a sample at all. Further, the user may wishto reconfirm the setting as a part of his or her best practices. Thereremains a need for tissue sampling devices capable of obtaining varyingamounts of tissue depending on a particular situation, and which permitseasy confirmation that the device is set for a desired sample size.

SUMMARY

Among other things, there is disclosed tissue sample acquisitiondevices, such as biopsy needles, that include a handle and a samplingportion. In particular embodiments, the handle has an upper surfaceadapted to generally face a user during use of the device, and which hasfirst and second openings. The sampling portion has a slide memberadapted to slide with respect to the upper surface of the handle, anelongated needle at least partially extending from the handle, and a hubconnecting the needle and the slide member. The sampling portionincludes at least one visually contrasting portion, having animmediately observable visual contrast with one or more adjacent partsof the sampling portion and with the handle. At least part of thesampling portion and the handle are movable with respect to each otherbetween at least a first relative configuration (corresponding to anunarmed state, e.g. not ready for firing) and a second relativeconfiguration (corresponding to an armed state, e.g. ready for firing).When the sampling portion and handle are in the first relativeconfiguration, at least part of the at least one visually contrastingportion is visible through the first opening, and when the samplingportion and handle are in the second relative configuration, at leastpart of the at least one visually contrasting portion is visible throughthe second opening.

Certain embodiments place the at least one visually contrasting portionas at least part of the slide member, and/or as at least part of thehub. The hub may be a part fitted into the slide member, the slidemember being of substantially the same color as the handle, and the hubat least partially of a color visually contrasting with the slidemember. As particular examples, the hub or other visually contrastingportion may be of a solid color that is easily contrasted with thegeneral color of the handle. Where the cannula is partially within thehandle and emerges from the handle at a particular location, the firstopening may be closer to that particular location than is the secondopening. The handle's longitudinal axis (e.g. an axis generally parallelto a portion of the elongated needle adjacent to or within the handle)may be generally parallel to a line connecting the first and secondopenings. Alternatively, the first opening can be laterally offset to afirst side of the longitudinal axis and the second opening laterallyoffset to a second side of the longitudinal axis, so that when the uppersurface of the handle is observed, the longitudinal axis is between andnot intersecting the first and second openings. The sampling portion canhave multiple visually contrasting portions, for example first andsecond such portions, and in the first relative configuration a firstvisually contrasting portion is visible through the first opening, andin the second relative configuration a second visually contrastingportion is visible through the second opening. Such multiple visuallycontrasting portions can include different colors. The first relativeconfiguration may be a relative position between the slide member andthe upper surface of the handle wherein the slide member is held at restrelative to the surface, and the second relative configuration is arelative position between the slide member and the surface wherein theslide member has been retracted from the first relative configurationand is held at rest relative to the surface.

In other embodiments, a biopsy needle or other tissue sample acquisitiondevice includes a handle that has a surface with first and secondopenings. A sampling portion has an elongated cannula that at leastpartially extends from the handle connected to a slide member adapted toslide with respect to the surface. The sampling portion has at least onevisually contrasting portion, the at least one visually contrastingportion having an immediately observable visual contrast with one ormore adjacent parts of the handle. At least part of the sampling portionand the handle are movable with respect to each other between at least afirst relative configuration and a second relative configuration. Thefirst relative configuration corresponds to a first armed stateoperationally adapted to result in obtaining a first sample size, andthe second relative configuration corresponds to a second armed stateoperationally adapted to result in obtaining a second sample sizedifferent from the first sample size. When the sampling portion andhandle are in the first relative configuration, at least part of the atleast one visually contrasting portion is visible through the firstopening. When the sampling portion and handle are in the second relativeconfiguration, at least part of the at least one visually contrastingportion is visible through the second opening.

The slide member can include, in particular embodiments, first andsecond visually contrasting portions and a longitudinal axis, with thefirst and second visually contrasting portions offset from each otherlongitudinally and offset laterally from and on respective sides of thelongitudinal axis. In the noted first relative configuration, the firstvisually contrasting portion is visible through the first opening, andin the second relative configuration, the second visually contrastingportion is visible through the second opening. The at least one visuallycontrasting portion is at least part of a hub of the cannula in certainembodiments, and in others may be part(s) of the slide member.Embodiments are disclosed in which, in the first relative configuration,a different view is visible through the second opening, the differentview including one of (a) a part of the sampling portion visuallysimilar to an area adjacent the second opening and (b) empty space.Similarly, in the second relative configuration, a different view may bevisible through the first opening, the different view comprising one of(a) a part of the sampling portion visually similar to an area adjacentthe second opening and (b) empty space.

Embodiments of a tissue sample acquisition device (e.g. biopsy needle)that include a handle with a first observation area and a secondobservation area and a sampling portion including an elongated memberare disclosed. The sampling portion and the handle have at least a firstrelative configuration and a second relative configuration. The firstrelative configuration corresponds to an operative state that is eitherunarmed or armed to enable the sampling portion to capture a size oftissue sample. The second relative configuration corresponds to anoperative state that is armed to enable the sampling portion to capturea size of tissue sample. When the sampling portion and handle are in thefirst relative configuration, the first observation area has ahighlighted condition, and when the sampling portion and handle are inthe second relative configuration, the second observation area has ahighlighted condition. A “highlight” or “highlighted condition”indicates making more noticeable, drawing attention, or making stand outcompared to adjacent areas or items. In certain embodiments, the firstand second observation areas cannot have their respective highlightedconditions at the same time. In examples in which the first observationarea is an opening, the highlighted condition of the first observationarea can include visibility of a visually contrasting portion of thesampling portion through the opening. The first and second observationareas may be at least one of (a) longitudinally separated from eachother, and (b) laterally offset from each other on respective sides of alongitudinal axis of the handle.

Examples include devices having a handle with opening(s) observable by auser and a needle or cannula portion movable with respect to handle. Inone operational state, a portion of the cannula (or a slide memberassociated with it) having a visual contrast is viewable through anopening in the handle, to advise the user of the device's operationalstate. One contrasting part of the cannula or slide member may beselectively viewable in two windows, each window indicating a respectiveoperative state. Two contrasting parts of the cannula or slide membermay be selectively viewable in two openings, or additional openingsand/or contrasting portions may be provided for devices capable ofmultiple throw-lengths.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of parts of an embodiment of abiopsy needle system according to the present disclosure.

FIG. 2 is a top view of an assembled embodiment as in FIG. 1.

FIG. 3A is a top view of a portion of an embodiment as in FIG. 1.

FIG. 3B is a top view of a different embodiment of the portion of FIG.3A.

FIG. 3C is a cross-sectional view of the embodiment shown in FIG. 3A.

FIG. 4A is a top view of an example of selected portions usable with theembodiment of FIG. 3A.

FIG. 4B is a top view of an example of selected portions usable with theembodiment of FIG. 3A.

FIG. 4C is a top view of an example of selected portions usable with theembodiment of FIG. 3B.

FIG. 5A is a top view of a portion of an embodiment as in FIG. 1 in afirst (e.g. unarmed) configuration.

FIG. 5B is a top view of a portion of the embodiment of FIG. 1 in asecond (e.g. armed) configuration.

FIG. 6A is a top view of a portion of an embodiment as in FIG. 1 in afirst (e.g. unarmed) configuration, with an embodiment as in FIG. 3Aattached.

FIG. 6B is a top view of a portion of the embodiment of FIG. 1 in afirst (e.g. armed) configuration, with an embodiment as in FIG. 3Aattached.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the purposes of promoting an understanding of the principles of thedisclosure, reference will now be made to certain embodiments andspecific language will be used to describe the same. It willnevertheless be understood that no limitation of the scope of thisdisclosure and the claims is thereby intended, such alterations, furthermodifications and further applications of the principles describedherein being contemplated as would normally occur to one skilled in theart to which this disclosure relates. In several figures, where thereare the same or similar elements, those elements are designated with thesame or similar reference numerals.

Referring now generally to the drawings, there is shown an embodiment ofa device for acquiring one or more tissue samples, in the particularform of a biopsy needle 20. Needle 20 includes an inner member or stylet22, an outer cannula 24 and a handle 26. Stylet 22 is slidable withincannula 24, and both are connected to and operable by handle 26 in thisembodiment. Stylet 22 is connected to a slide member 30, which is withinand slidable with respect to handle 26 in this embodiment.

Stylet 22 has an elongated body 32 extending between an proximal end 34and a distal end 36. Elongated body 32 is at least substantiallycylindrical in the illustrated embodiment for ease of use andmanufacture. Proximal end 34 is connected directly or indirectly tohandle 26, for operation during a biopsy procedure as will be furtherdiscussed below. Distal end 36 may be sharpened, for example by grindinga surface 38 that is planar and oblique to the longitudinal axis ofcannula 22.

Proximal of surface 38 there is formed in stylet 22 a notch or indent40. Notch 40 is provided so that tissue to be biopsied enters notch 40and is cut off and contained in notch 40, as further discussed below. Asa particular example, notch 40 has a length measured in a longitudinaldirection of at least 20 mm, so that in such a case a maximumthrow-length for needle 20 is at least 20 mm.

The illustrated embodiment of cannula 24 is tubular, having an elongatedbody 50 extending between a proximal end 52 and a distal end 54.Proximal end 52 is directly or indirectly connected to handle 26 foroperation during the biopsy procedure. Distal end 54 includes asharpened surface 60. In the illustrated embodiment, an essentiallyplanar oblique section is taken through cannula 24, so that end surface60 is formed with sharp edges. A hub 62 or other connection is providedon cannula 24 in this embodiment to link cannula 24 to slide member 30.

Handle 26 is connected to and operates each of stylet 22 and cannula 24so that stylet 22 is within cannula 24, and so that stylet 22 andcannula 24 are slidable with respect to each other. An example ofstructure usable as part of handle 26 is that currently used withQUICK-CORE® products sold by Cook Medical (Bloomington, Ind.).Embodiments with parts or structures potentially usable in handle 26 areshown in U.S. Provisional Application No. 61/261,857 (filed on Nov. 17,2009), U.S. application Ser. No. 13/293,162 (filed on Nov. 10, 2011),and U.S. application Ser. No. 13/433,801 (filed on Mar. 29, 2012), theentireties of which are incorporated herein by reference.

Handle 26, in the illustrated embodiment, includes a trigger or actuator70 connected to slide member 30, and a cover or housing 80. Handle 26includes finger holds 82 which are substantially circular in thisembodiment, and a central track or channel 83 in which slide member 30is slidable forward and backward (proximally and distally). One or morecatches (not shown) are positioned in channel 83 for holding slidemember 30 when slide member 30 is pulled sufficiently proximally.Actuator 70 includes a grip or pad 86 positioned at its proximal end inthis embodiment, and a distally-extending finger 87 with an end boss 88that can engage slide member 30 to draw it proximally.

Handle 26 further includes openings 90 in this embodiment, for exampletwo openings 90 a, 90 b shown in a particular instance through cover 80.Openings 90 are (or are part of) an observation area in handle 26. Theterm “opening” refers generally to the concept of permittingvisualization, and includes uncovered apertures as well as those coveredby transparent materials (e.g. a clear plastic window). Openings 90 arelarge enough for a user to be able to easily see through them and intohandle 26, from a distance of at least one to two feet from handle 26.The example of FIGS. 1, 2 and 3A shows openings 90 as being linearlyoriented with each other, with their centers on a line that is parallelor along a longitudinal axis of handle 26, and/or on a line that isparallel to the direction of travel of slide member 30. The example ofFIG. 3B shows openings 90 that are offset from each other and from alongitudinal axis of handle 26 as viewed from above. A line between thecenters of openings 90 in FIG. 3B is substantially perpendicular to alongitudinal axis of handle 26 and the direction of travel of slidemember 30. The illustrated embodiments show at least first and secondopenings 90, and it will be understood that one opening or additional(e.g. three or more) openings may be present in other embodiments. Inparticular embodiments, respective legends adjacent each opening 90indicates a particular configuration, as will be further discussedbelow. Cover 80 fits over channel 83, covering and protecting slidingengagement between slide member 30 and other internal parts of handle26, e.g. from debris and interference.

Slide member 30 is in the form of a substantially rectangular solid inwhole or part in the illustrated embodiment, and is movable withinchannel 83 of handle 26. Slide member 30 is coupled to a proximalportion of cannula 24, e.g. by inserting hub 62 or other portion ofcannula 24 into an opening 94 (which may be complementary to hub 62 orother portion of cannula 24) of slide member 30, with cannula 24extending from slide member 30. Slide member 30 has an upper surface 96,which as illustrated may be substantially planar throughout andsubstantially flush with hub 62 when hub 62 is seated in opening 94.When slide member 30 is within channel 83, upper surface 96 faces and isdirectly under openings 90 through cover 80. In this embodiment,actuator 70 is connected to stylet 22. A spring (not shown) is providedadjacent to slide member 30 to propel slide member 30 and cannula 24forward, as discussed further below. The spring engages slide member 30and an internal surface of housing 26.

At least one visually contrasting area is provided on or in one or moreof the parts that move with respect to handle 26 or parts of it. In theexamples of FIGS. 4A and 4B, a visually contrasting section 100 is on aportion of upper surface 96 of slide member 30 and/or on part or all ofan exposed portion of hub 62 of cannula 24. The embodiment of FIG. 4Aplaces visually contrasting section 100 on or in hub 62, which isadjacent or surrounded by portions of slide member 30 that are visuallysimilar to handle 26 or portions of it surrounding openings 90. Theembodiment of FIG. 4B places visually contrasting section 100 on uppersurface 96 of slide member 30, with adjacent or surrounding portions ofthe surface 96 that are visually similar to each other and to at leastpart of handle 26 adjacent to or surrounding openings 90. The example ofFIG. 4C shows slide member 30 including two separated visuallycontrasting sections 100, offset from each other longitudinally andoffset on either side of a longitudinal axis A of slide member 30. Asfurther explained below, the visually contrasting area(s) 100 andopenings 90 are intended to at least partially align at particularconfigurations of needle 20, e.g. at particular relative locations ofslide member 30 with respect to handle 26, so that the user can observeone or more visually contrasting area(s) 100 through one or moreopening(s) 90.

By “visually similar” it is meant that the characteristics observable tothe eye of a user are very close to or identical to those of otherparts, such as the cover 80 and/or other parts of handle 26. Forexample, if cover 80 is a white or beige color, a lighter neutral color(e.g. white, beige or similar off-white) would be visually similar. By“visually contrasting” it is meant that the characteristics observableto the eye of a user are dissimilar to other parts. Thus, if cover 80 isa white or beige color, visually contrasting colors could include green,red, blue, black and/or others. Further, a visually contrasting area canhave or include markings or textures that visually contrast, such asstripes, dots, hatching or other features, particularly wheresurrounding or adjacent area(s) are of a solid color or have differentmarkings. It will be understood that combinations of color, marking,texture and/or other differences can be used to create visuallycontrasting areas 100.

Handle 26 is cocked or armed for use by pulling actuator 70 (e.g. viagrip 86) backward, i.e. out or away from finger grips 82 and/or the restof handle 26. With actuator 70 engaging slide member 30, when actuator70 is pulled, slide member 30 is pulled backward (proximally) within orwith respect to handle 26, compressing a spring until a catch engagesand holds slide member 30 to maintain an armed or cocked position.Pulling grip 86 proximally moves both cannula 24 and stylet 22 together,maintaining their respective tips at approximately the same location.

In particular embodiments, a needle 20 has a single armed configuration,corresponding to a single throw-length. In such cases, the needle iseither armed or unarmed, and the cannula 24 is either fully forward (inthe unarmed configuration) or is retracted and held against the force ofa compressed spring (in the armed configuration). In the unarmedconfiguration, a visually contrasting region 100 is visible through aparticular opening 90, e.g. the furthest forward opening 90 a. Adjacentthat furthest forward opening 90 a, as suggested above, may be a legendindicating “UNARMED” or similar notation, so that when a visuallycontrasting region 100 is visible through it, the user will understandthat needle 20 is unarmed. In the armed configuration, a visuallycontrasting region 100 is visible through a different particular opening90, e.g. the rearward opening 90 b. Adjacent that rearward opening 90 b,as suggested above, may be a legend indicating “ARMED” or similarnotation, so that when a visually contrasting region 100 is visiblethrough it, the user will understand that needle 20 is armed and capableof firing.

In other embodiments, a needle 20 has two or more armed configurations,each corresponding to a particular throw-length. For example, a twothrow-length needle may be armable or cockable to a first orintermediate position for a 10 millimeter throw-length, and to a secondor farthest position for a 20 millimeter throw-length. In such cases,the needle is either (1) unarmed, (2) armed for the first throw-length,or (3) armed for the second throw-length. In the first armedconfiguration (for the first throw-length), cannula 24 is retractedagainst spring force to a first location, and a visually contrastingregion 100 is visible through a particular opening 90, e.g. the furthestforward opening 90 a. Adjacent that furthest forward opening 90 a, assuggested above, may be a legend indicating the first throw-length (e.g.“10 MM” or similar notation), so that when a visually contrasting region100 is visible through the opening, the user will understand that needle20 is armed for the first throw-length. In the second armedconfiguration, a visually contrasting region 100 is visible through adifferent particular opening 90, e.g. the rearward opening 90 b.Adjacent that rearward opening 90 b, as suggested above, may be a legendindicating the second throw-length (e.g. “20 MM” or similar notation),so that when a visually contrasting region 100 is visible through it,the user will understand that needle 20 is armed for the secondthrow-length. In such embodiments, if a visually contrasting region isnot visible through either window, it indicates that needle 20 isunarmed. It will be understood that in other embodiments a third opening90 is placed in a location forward (more proximal) of an opening 90corresponding to a first (shorter) throw-length, perhaps with an“UNARMED” or similar legend, so that when unarmed a visually contrastingregion will be visible through such more-forward opening.

It will further be understood that additional throw-lengths can beprovided in a needle 20, with corresponding armed configurations (i.e.relative locations where slide member 30 is held with respect to handle26) and openings in handle 26. Regardless of the number of throw-lengthsprovided in a needle, openings and visually contrasting region(s) can beprovided so that a region shows through one opening when the needle isin one operational condition (e.g. armed for a particular throw-length,or unarmed), and a region shows through another opening when the needleis in a different operational condition (e.g. armed for anotherparticular throw-length, or simply armed).

Once needle 20 is cocked, the user can perform additional steps in orderto fire cannula 24 and obtain a tissue sample. In some embodiments,needle 20 can be primed by moving stylet 22 forward into tissue,exposing notch 40 at least partially beyond the distal end of cannula24. Needle 20 is fired to capture tissue within notch 40 by releasingspring 78 to move cannula 24 quickly forward over stylet 22 and notch40. For example, applying force (e.g. through actuator 70) to slidemember 30 and/or the catch holding it so as to release or overcome thehold and allow the compressed spring push to slide member 30 and thrustcannula 24 over notch 40 of stylet 22. Thus, in the illustratedembodiment firing the inserted and cocked needle 20 propels cannula 24over stylet 22, and particularly over notch 40 or the portion of notch40 that extends from the distal end of cannula 24. The cutting action ofcannula 24 via its sharpened distal end 60 during that movement seversand traps tissue within notch 40.

Handle 26 permits the user to be assured and to easily check whether thedevice is cocked or armed, and/or whether armed for the desiredthrow-length, when the distal end of the needle is within the patientand so not directly observable. The use of needle 20 will now bedescribed in the context of obtaining a sample of soft tissue fortesting purposes. It will be understood that methods for obtainingsamples of other tissues or for other purposes are also contemplated.

The surgeon or other medical professional first determines a location ina patient, with its depth under the skin, from which a tissue sample isdesired. In one embodiment, stylet 22 and cannula 24 of needle 20 areinitially in the above-noted first relative position, e.g. with thedistal ends of stylet 22 and cannula 24 substantially co-extant oradjacent. The user considers what length of sample he or she believes isneeded. The below-described example concerns a needle providing a choicebetween two throw lengths, e.g. 10 millimeters (with a first catchposition for slide member 30) and 20 millimeters (with a second catchposition for slide member 30).

The user cocks needle 20, as noted above, by pulling actuator 70 ofhandle 26 until slide member 30 catches at the desired position. In thecocked state, in this embodiment, stylet 22 and cannula 24 are in arelative position. Such arming of needle 20 can occur either prior toinsertion of needle 20 into the patient, or can occur when the distalend of needle 20 has been inserted to or adjacent to a desired locationin the patient.

The user places distal ends 36 and/or 54 of stylet 22 and/or cannula 24against the skin at a place proximate to the desired location, andinserts needle 20. Needle 20 forces a path through the skin andsubcutaneous tissue to a point in or just before the location from whicha sample is to be taken. If needle 20 has not previously been cocked orarmed for a desired throw-length, then that step can be performed withthe distal end of needle 20 inside the patient. Further manipulations toprime or otherwise prepare the needle for firing may be performed.

At any time the user may check to ensure that the needle is armed,and/or if the needle is armed for the desired throw-length. The user canlook down to handle 26 and observe openings 90. If the user observes anempty opening (e.g. no part of slide member 30 or hub 62 is visible) orif a visually similar region of slide member 30 and/or hub 62 is visiblethrough an opening, it is an indication to the user that the stateindicated by that opening is not the current state of the device. If theuser observes an opening through which a visually contrasting region(e.g. of slide member 30 and/or hub 62) is visible, it is an indicationto the user that the state indicated by that opening is the currentstate of the device.

Thus, in a needle 20 having two throw-lengths and separate openingsindicating each respective throw-length, the user can immediately tellwhich throw-length the needle is armed for. If the user observes avisually contrasting region through the opening corresponding to thefirst throw-length, he or she knows the needle is armed for thefirst-throw length. A visually similar region or an empty space may bevisible in the other opening. If a visually similar region or an emptyspace is visible in both openings, it is an indication that the needleis unarmed. As another example, in a needle having one armed condition,and respective openings indicating an armed and unarmed condition areprovided, in the armed condition a visually contrasting region will bevisible through the opening corresponding to the armed condition. Avisually similar or empty space may be visible through the openingcorresponding to the unarmed condition. Conversely, in the unarmedcondition a visually contrasting region will be visible through theopening corresponding to the unarmed condition, and a visually similaror empty space may be visible through the opening corresponding to thearmed condition. The user need not see the distal end of needle 20 inorder to determine whether it is armed as he or she desires.

Having verified that needle 20 is in the desired armed condition, theuser releases the hold on slide member 30, as indicated above, to firecannula 24 forward. Slide member 30 moves forward from its armed orcocked position to its unarmed or rest position (e.g. as far forward ashandle 26 will allow). The cutting action of cannula 24 severs thesample of tissue within notch 40. Tissue outside notch 40, eitherradially or longitudinally, is not trapped in notch 40 between cannula24 and stylet 22.

After firing, needle 20 is withdrawn from the patient. Once needle 20 iswithdrawn, the tissue sample is removed by cocking and priming needle20, as indicated above, to expose notch 40 and the tissue within it. Thetissue sample can be extracted from notch 40 using a forceps or othertool, or in some embodiments by inverting notch 40 and allowing thetissue to drop out of notch 40 into a specimen dish or other container.If the user determines that additional sample(s) are needed, then theprocedure above can be repeated to obtain such samples.

While an illustration of needle 20 discussed above has two throw-lengthsettings, exemplified as 10 millimeters and 20 millimeters, it will beunderstood that other throw lengths can be used in place of one or bothof such lengths. Further, as noted previously it will be understood thatthree or more throw-length settings may be provided in a needle systemor kit, by providing three or more catches each holding slide member 30at respective different positions with respect to handle 26. As oneexample, a system or kit may be provided having sterilized partsincluding a needle 20 with a largest throw-length of 20 millimeters, andtwo smaller, intermediate lengths, such as 15 and 10 millimeters.

As used herein, the term “throw length” is intended to indicate ameasurement of the length of a tissue sample obtained and/or thedistance a part is moved forward in use of the device. For example, a 20millimeter throw length for the embodiments noted above indicates thatstylet 22 is advanced in the priming step so that approximately 20millimeters of notch 40 (or the entire notch 40 if its length is 20millimeters, in this example) is exposed from cannula 24.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly certain specific embodiments have been shown and that all changesand modifications that come within the spirit of the disclosure aredesired to be protected. It is to be understood that features describedwith respect to one embodiment or aspect of the disclosure can be usedwith other embodiments or aspects of the disclosure.

1. A tissue sample acquisition device, comprising: a handle, the handlehaving an upper surface adapted to generally face a user during use ofthe device, the upper surface having at least first and second openings;an actuator adapted to be pulled and pushed with respect to the handle;a sampling portion having a slide member operatively connected to theactuator and adapted to slide with respect to the upper surface of thehandle, an elongated cannula at least partially extending from thehandle, and a hub connecting the cannula and the slide member, thesampling portion having at least one visually contrasting portion, theat least one visually contrasting portion having an immediatelyobservable visual contrast with one or more adjacent parts of thesampling portion and with the handle; wherein at least part of thesampling portion and the handle are movable with respect to each otherbetween at least a first relative configuration and a second relativeconfiguration, the first relative configuration corresponding to anunarmed state in which the cannula is fully forward and the secondrelative configuration corresponding to an armed state in which theactuator is pulled back, and wherein when the sampling portion andhandle are in the first relative configuration, at least part of the atleast one visually contrasting portion is visible through the firstopening, and when the sampling portion and handle are in the secondrelative configuration, at least part of the at least one visuallycontrasting portion is visible through the second opening.
 2. The deviceof claim 1, wherein the at least one visually contrasting portion is atleast part of the slide member.
 3. The device of claim 1, wherein the atleast one visually contrasting portion is at least part of the hub. 4.The device of claim 3, wherein the hub is a part fitted into the slidemember, the slide member being of substantially the same color as thehandle, and the hub at least partially of a color visually contrastingwith the slide member.
 5. The device of claim 4, wherein the hub is of asolid color.
 6. The device of claim 1, wherein the handle has alongitudinal axis generally parallel to a portion of the elongatedneedle adjacent to or within the handle, and wherein a line connectingthe first and second openings is generally parallel to the longitudinalaxis.
 7. The device of claim 1, wherein the handle has a longitudinalaxis generally parallel to a portion of the elongated cannula adjacentto or within the handle, and wherein the first opening is laterallyoffset to a first side of the longitudinal axis and the second openingis laterally offset to a second side of the longitudinal axis, so thatwhen the upper surface of the handle is observed, the longitudinal axisis between and not intersecting the first and second openings.
 8. Thedevice of claim 1, wherein the sampling portion includes first andsecond visually contrasting portions, and wherein in the first relativeconfiguration the first visually contrasting portion is visible throughthe first opening, and in the second relative configuration the secondvisually contrasting portion is visible through the second opening. 9.The device of claim 8, wherein the first and second visually contrastingportions include different colors.
 10. The device of claim 1, whereinthe first relative configuration is a relative position between theslide member and the surface wherein the slide member is held at restrelative to the surface, and the second relative configuration is arelative position between the slide member and the surface wherein theslide member has been retracted from the first relative configurationand is held at rest relative to the surface.
 11. (canceled)
 12. Thedevice of claim 1, wherein said slide member includes first and secondvisually contrasting portions and a longitudinal axis, wherein the firstand second visually contrasting portions are offset from each otherlongitudinally and offset laterally from and on respective sides of thelongitudinal axis.
 13. The device of claim 12, wherein in the firstrelative configuration, the first visually contrasting portion isvisible through the first opening, and in the second relativeconfiguration, the second visually contrasting portion is visiblethrough the second opening.
 14. (canceled)
 15. The device of claim 1,wherein in the first relative configuration, a different view is visiblethrough the second opening, the different view comprising one of (a) apart of the sampling portion visually similar to an area adjacent thesecond opening and (b) empty space.
 16. The device of claim 1, whereinin the second relative configuration, a different view is visiblethrough the first opening, the different view comprising one of (a) apart of the sampling portion visually similar to an area adjacent thesecond opening and (b) empty space.
 17. A tissue sample acquisitiondevice, comprising: a handle having a first observation area and asecond observation area, each observation area comprising a respectiveopening through the handle and spaced from each other; an actuatoradapted to be pulled and pushed with respect to the handle; a samplingportion operatively connected to the actuator and including an elongatedmember, wherein the sampling portion and the handle have at least afirst relative configuration and a second relative configuration, thefirst relative configuration corresponding to an operative state that iseither unarmed or armed to enable the sampling portion to capture a sizeof tissue sample, and the second relative configuration corresponding toan operative state that is armed to enable the sampling portion tocapture a different size of tissue sample, and wherein when the samplingportion and handle are in the first relative configuration, the firstobservation area has a highlighted condition, and when the samplingportion and handle are in the second relative configuration, the secondobservation area has a highlighted condition.
 18. The device of claim17, wherein the first and second observation areas cannot have theirrespective highlighted conditions at the same time.
 19. The device ofclaim 17, wherein the highlighted condition of the first observationarea includes visibility of a visually contrasting portion of thesampling portion through the opening.
 20. The device of claim 17,wherein the first and second observation areas are at least one of (a)longitudinally separated from each other, and (b) laterally offset fromeach other on respective sides of a longitudinal axis of the handle.